EUCTR2012-003137-41-SK进行中（未招募）不适用
DOUBLE-BLIND STUDY IN PAEDIATRIC EPILEPTIC SUBJECTS AGED FROM 5 TO LESS THAN 8 YEARS TO COMPARE THE SUBJECT PREFERENCE FOR ESL SUSPENSION FORMULATION WITH ALTERNATIVE FLAVOURS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A written informed consent form signed by the subject’s parent(s) or guardian(s) and an assent form for any 7-year-old subjects signed by subjects.
- •Male or female, between the age of 5 to <8 years.
- •Diagnosed with partial-onset epilepsy.
- •Is considered, in the opinion of the investigator, to be able to make the required taste assessment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorder.
- •Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
- •Strong congestion, flu, or any other acute illness that could influence the child’s sense of taste.
- •A known swallowing or taste perception problem.
- •Currently or previously treated with ESL.
- •Concomitant participation in another drug clinical trial.
- •Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
研究者
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